103842 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

FDA’s Center for Drug Evaluation and 

Research (CDER), Center for Biologics 

Evaluation and Research, Office of the 

Commissioner, and any other Centers 

will use this mechanism to test 

communications and social and 

behavioral methods about regulated 

drug products on a variety of subjects 

related to consumer, patient, or 

healthcare professional perceptions, 

beliefs, attitudes, behaviors, and use of 

drug and biological products and related 

materials. These subjects include social 

and behavioral research, decisionmaking processes, and communication 

and behavioral change strategies. 

Further, in addition to overseeing the 

safety of drug products when used 

according to approved drug labeling or 

as directed by a healthcare provider, 

CDER conducts studies on topics related 

to the safe and effective use of drug 

products, and emerging safety issues in 

areas such as: (1) nonmedical use of 

approved drug products; (2) use of 

unapproved and falsified (i.e., 

counterfeit, fake) drug products; (3) use 

of botanical substances (e.g., cannabis 

derived products); (4) controlled 

substance prescribing decisions; (5) 

bystander response to drug overdoses; 

and (6) potentially false or misleading 

information about drug products. 

Reliable data on these and related topics 

are a critical first step to understanding 

whether further studies or action is 

needed to protect public health. 

Because often data on these topics are 

not collected as part of routine 

healthcare delivery or via established 

Federal surveys, FDA requires the 

development and validation of novel 

instruments (i.e., interview and focus 

group guides, questionnaires) and 

approaches to gathering data on 

emerging safety issues the methods used 

to create and validate these instruments 

may include interviews, focus groups, 

small group discussions, pilot and test/ 

re-test survey launches, and external 

validation against benchmark surveys. 

In conducting research in these areas, 

FDA will need to employ the following 

validation methodology: (1) research to 

assess knowledge, perceptions, and 

experiences related to topics in the 

above-mentioned areas with specific 

target populations; (2) techniques to 

evaluate sampling and recruitment 

methods; and (3) evaluations of the 

validity and reliability of survey 

questionnaires in target populations. 

In accordance with 5 CFR 1320.8(d), 

FDA published a 60-day notice for 

public comment on the proposed 

collection of information in the Federal 

Register of April 23, 2024 (89 FR 

30381). Although one comment was 

received, it was not responsive to the 

four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

Annually, FDA projects about 25 

social and behavioral studies using the 

variety of test methods listed in this 

document. FDA is revising this burden 

to account for the number of studies we 

have received in the last 3 years and to 

better reflect the scope of the 

information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Interviews and Surveys ........................................ 126,770 1 126,770 0.25 (15 minutes) .......... 31,693 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, our burden estimate for 

this information collection reflects an 

overall increase of 17,300 responses 

with a corresponding increase of 4,325 

hours. We attribute this adjustment to 

the need to validate information in 

specific areas. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30224 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meetings of the Council on Graduate 

Medical Education 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Council on 

Graduate Medical Education (COGME or 

Council) will hold public meetings for 

the 2025 calendar year (CY). 

Information about COGME, agendas, 

and materials for these meetings can be 

found on the COGME website at: 

https://www.hrsa.gov/advisorycommittees/graduate-medical-edu. 

DATES: COGME meetings will be held 

on: 

• April 10, 2025, 8 a.m.–5 p.m. 

eastern time (ET) and April 11, 2025, 8 

a.m.–2 p.m. ET. 

• September 11, 2025, 8 a.m.–5 p.m. 

ET and September 12, 2025, 8 a.m.–4 

p.m. ET. 

ADDRESSES: Meetings will be held inperson, by teleconference, and/or on a 

video conference platform. In-person 

meetings will be held at 5600 Fishers 

Lane, Rockville, Maryland 20857. For 

updates on how the meetings will be 

held, instructions for joining meetings, 

and any other updates, visit the COGME 

website 30 business days before the date 

of the meeting at https://www.hrsa.gov/ 

advisory-committees/graduate-medicaledu/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Shane Rogers, Designated Federal 

Officer, Division of Medicine and 

Dentistry, Bureau of Health Workforce, 

HRSA, 5600 Fishers Lane, Room 15N39, 

Rockville, Maryland 20857; 301–443– 

5260; or SRogers@hrsa.gov. 

SUPPLEMENTARY INFORMATION: COGME 

provides advice and recommendations 

to the Secretary of HHS and Congress on 

policy, program development, and other 

matters of significance regarding the 

issues listed in section 762(a)(1) of the 

Public Health Service Act. Issues 

addressed by the COGME include the 

supply and distribution of the physician 

workforce in the United States, 

including any projected shortages or 

excesses, issues related to foreign 

medical school graduates, the nature 

and financing of undergraduate and 

graduate medical education, 

appropriation levels for certain 

programs under title VII of the Public 

Health Service Act, and deficiencies in 

databases concerning the supply and 

distribution of the physician workforce 

and postgraduate programs for training 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103843 

physicians. COGME submits reports not 

less than every 5 years to the Secretary 

of HHS; the Senate Committee on 

Health, Education, Labor, and Pensions; 

and the House of Representatives 

Committee on Energy and Commerce. 

Additionally, COGME encourages 

entities providing graduate medical 

education to conduct activities to 

voluntarily achieve the 

recommendations of the Council related 

to appropriate efforts to be carried out 

by hospitals, schools of medicine, 

schools of osteopathic medicine, and 

accrediting bodies with respect to the 

supply and distribution of physicians in 

the United States; current and future 

shortages or excesses of physicians in 

medical and surgical specialties and 

subspecialties; and issues relating to 

foreign medical school graduates, 

including efforts for changes in 

undergraduate and graduate medical 

education programs. 

Since priorities dictate meeting times, 

be advised that start times, end times, 

and agenda items are subject to change. 

For CY 2025 meetings, agenda items 

may include, but are not limited to: 

discussions on team-based care and the 

Senate Finance Committee’s Medicare 

Graduate Medical Education draft 

policy document. Refer to the COGME 

website listed above for all current and 

updated information concerning the CY 

2025 COGME meetings, including 

agendas and meeting materials that will 

be posted 30 calendar days before the 

meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to COGME 

should be sent to Shane Rogers using 

the contact information above at least 5 

business days before the meeting date. 

Individuals who need special assistance 

or another reasonable accommodation 

should notify Shane Rogers using the 

contact information listed above at least 

10 business days before the meeting(s) 

they wish to attend. Since all in-person 

meetings will occur in a federal 

government building at 5600 Fishers 

Lane, Rockville, MD 20857, attendees 

must go through a security check to 

enter the building. Members of the 

public must notify the Designated 

Federal Officer of their intent to attend 

the in-person meeting 10 business days 

before the meeting. Non-U.S. citizen 

attendees must notify the Designated 

Federal Officer of their planned 

attendance at least 20 business days 

prior to the meeting to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–30076 Filed 12–18–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meetings of the National Advisory 

Council on Nurse Education and 

Practice 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Council on Nurse Education 

and Practice (NACNEP) will hold public 

meetings for the 2025 calendar year 

(CY). Information about NACNEP, 

agendas, and materials for these 

meetings can be found on the NACNEP 

website at: https://www.hrsa.gov/ 

advisory-committees/nursing/meetings. 

DATES: NACNEP meetings will be on (all 

in Eastern Time): 

• March 5, 2025, 10 a.m.–4 p.m. and 

March 6, 2024, 10 a.m.–4 p.m. 

• May 14, 2025, 10 a.m.–4 p.m. 

• August 6, 2025, 10 a.m.–4 p.m. and 

August 7, 2025, 10 a.m.–4 p.m. 

• December 4, 2024, 8 a.m.–5 p.m. 

and December 4, 2025, 8 a.m.–2 p.m. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or video 

conference. For updates on how the 

meeting will be held, visit the NACNEP 

website 30 business days before the date 

of the meeting, where instructions for 

joining meetings either in-person or 

remotely will also be posted. In-person 

NACNEP meetings will be held at 5600 

Fishers Lane, Rockville, Maryland, 

20857. For meeting information 

updates, go to the NACNEP website 

meeting page at https://www.hrsa.gov/ 

advisory-committees/nursing/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Justin Bala-Hampton, Designated 

Federal Officer, Bureau of Health 

Workforce, HRSA, 5600 Fishers Lane, 

Rockville, Maryland, 20857; 301–945– 

9880; or JBala-Hampton@hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACNEP 

provides advice and recommendations 

to the Secretary of Health and Human 

Services on policy, program 

development, and other matters of 

significance concerning the activities 

under Title VIII of the Public Health 

Service Act, including the range of 

issues relating to the nurse workforce, 

education, and practice improvement. 

NACNEP also prepares and submits an 

annual report to the Secretary of Health 

and Human Services and Congress 

describing its activities, including 

NACNEP’s findings and 

recommendations concerning activities 

under Title VIII, as required by the 

Public Health Service Act. 

Since priorities dictate meeting times, 

be advised that start times, end times, 

and agenda items are subject to change. 

For CY 2025 meetings, agenda items 

may include, but are not limited to, the 

nursing workforce (e.g., nursing 

shortage, distribution, supply, and 

access) nursing practice improvement, 

nursing education, nursing work 

environment and support, and other 

Title VIII program activities. Refer to the 

NACNEP website listed above for all 

current and updated information 

concerning the CY 2025 NACNEP 

meetings, including draft agendas and 

meeting materials that will be posted 30 

calendar days before the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to NACNEP 

should be sent to Justin Bala-Hampton 

using the contact information above at 

least 5 business days before the meeting 

date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Justin 

Bala-Hampton using the contact 

information listed above at least 10 

business days before the meeting(s) they 

wish to attend. Since all in-person 

meetings will occur in a federal 

government building, attendees must go 

through a security check to enter the 

building. Non-U.S. citizen attendees 

must notify HRSA of their planned 

attendance at least 20 business days 

prior to the meeting to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–30070 Filed 12–18–24; 8:45 am] 

BILLING CODE 4165–15–P 


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